Comparing tissue glue to suturing in gum graft surgery
| ISRCTN | ISRCTN10301784 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10301784 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | MS2773 |
| Sponsor | Damascus University |
| Funder | Damascus University |
- Submission date
- 20/12/2019
- Registration date
- 02/01/2020
- Last edited
- 01/07/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
This study aims to compare using glue or suturing (stitches) to hold gum tissue in place during gum grafting surgery.
Who can participate?
Healthy adults aged 18-45 years who are non-smokers
What does the study involve?
Two pieces of gum will be grafted for each patient. One will be attached using suturing, the other with the glue. The size of the grafts, their healing and the patient's pain will be assessed afterwards.
What are the possible benefits and risks of participating?
Dentists commonly use suturing and glue in these procedures. Both are safe and should not cause any additional risks, other than those involved in the gum grafting procedure. All participants will receive the same treatment.
Where is the study run from?
Damascus University (Syria)
When is the study starting and how long is it expected to run for?
March 2019 to January 2020
Who is funding the study?
Damascus University (Syria)
Who is the main contact?
Dr Mohamed Aghiad Alhourani, agheadhou@hotmail.com
Contact information
Scientific
Tanzeem Kafafrsouseh - Building N.244
Damascus
-
Syria
 ORCID ID |
0000-0002-0444-7091 |
|---|---|
| Phone | +963 992325732 |
| agheadhou@hotmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized internal-controlled trial |
| Secondary study design | Randomised parallel trial |
| Participant information sheet | ISRCTN10301784_PIS_02Jan2020.pdf |
| Scientific title | Comparison between using tissue adhesive (N-butyl cyanoacrylate/octyl cyanoacrylate) and conventional sutures in free gingival graft surgery |
| Study objectives | We are trying to test the efficacy of a new formula of cyanoacrylate tissue adhesive (IceBerg Glue tissue adhesive), and comparing it to traditional methods in free gingival graft surgery. |
| Ethics approval(s) | Approved 04/08/2019, Damascus University Rector (Baramkeh, Damascus, Syria; +966 55 506 3806; no email), ref: 2773MS |
| Health condition(s) or problem(s) studied | Free gingival (gum) graft treatment for absence or insufficiency of attached gingiva |
| Intervention | This study is a split mouth randomized clinical trial. The patient chose a piece of paper to decide which side was to be sutured and which was to be sealed with tissue adhesive and the paper was opened just before the operation. The patient's palate was anaesthetized. Then one long piece of the free gingival graft 1-1.5 mm thickness was harvested from the palate (from the second molar to the first pre-molar), then it was divided into two equal pieces for the vestibuloplasty. The grafted area was made by a small blade to gain a depth about 10 mm and was extended along the targeted area on two sides.One piece was fixed in its bed using nylon sutures. The other one was put in its bed and the dentist held his finger on it for 5 min to encourage its initial stability. Then 4 drops of the tissue adhesive "IceBerg Glue" were applied. Patients returned after 1 week to have the sutures removed. They were followed up at 2 weeks, 1 month, 2 months, 3 months, and 6 months. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Shrinkage of the graft assessed using at 2 months, 3 months and 6 months. A standard sizing template of known size is placed beside the graft and digital photographs are taken. Software is used to calculate the size of the graft by comparing it with the template in the images. |
| Key secondary outcome measure(s) |
1. Recipient site healing assessed using the modified early-wound healing index (MEHI) at 1 week, 2 weeks, 1 month and 2 months |
| Completion date | 10/01/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 45 Years |
| Sex | All |
| Target sample size at registration | 12 |
| Total final enrolment | 12 |
| Key inclusion criteria | 1. Attached gingiva ≤1 mm 2. No systemic diseases 3. Non-smoker 4. Gingival inflammation and plaque indexes <20% at time of surgery 5. Aged 18-45 years |
| Key exclusion criteria | 1. Systemic disease that would interfere with the healing process 2. Has undergone previous periodontal surgery 3. Poor endodontic treatment 4. Tooth mobility 5. Severe gingival pigmentation 6. Pregnant 7. Radiation-exposed 8. Alcoholic 9. Receiving diuretic treatment 10. Taking hormone alternatives 11. Immunocompromised |
| Date of first enrolment | 06/04/2019 |
| Date of final enrolment | 10/06/2019 |
Locations
Countries of recruitment
- Syria
Study participating centre
Mazzah High Way
Damascus
-
Syria
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Dr.Mhd Aghiad Alhourani (agheadhou@hotmail.com/dr.aghiadalhourani@hotmail.com) or the Higher Education Council at Damascus University by application in person. All photos for all the participants will be available, along with all the data and the statistical analysis after Dr Alhourani has finished follow-up and collected all the data. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 30/06/2022 | 01/07/2022 | Yes | No | |
| Participant information sheet | 02/01/2020 | 02/01/2020 | No | Yes | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- ISRCTN10301784_PIS_02Jan2020.pdf
- Uploaded 02/01/2020
Editorial Notes
01/07/2022: Publication reference added.
01/02/2022: The intention to publish date was changed from 15/03/2020 to 02/04/2022. Total final enrolment added.
03/01/2020: The plain English summary has been added.
02/01/2020: The participant information sheet has been uploaded.
02/01/2020: Trial's existence confirmed by Damascus University.
